JP2007513692A - Cell collection device - Google Patents

Abstract

Various cytological devices and methods for their use for collecting cell specimens from the mammalian body are provided. The disclosed devices and methods are minimally invasive. Some devices include a needle having an inner lumen extending from the proximal end to the distal end. A stylet having a proximal end and a distal end is inserted into the inner lumen of the needle to close the inner lumen of the needle when the cell specimen is cut to prevent contamination inside the needle. The tip of the stylet may be sharp and extend beyond the tip of the needle to cut the cell specimen. The device also includes a cell collection device that is adapted to be inserted into the inner lumen of the needle when the stylet is withdrawn from the inner lumen of the needle. The tip of the cell collection device is extended beyond the tip of the needle to collect a cell sample and is drawn into the needle after sample collection. In some embodiments, the cell collection device comprises an elongated member having a plurality of bristles near its tip. In another embodiment, the cell collection device comprises an inflatable balloon. In another embodiment, the cell collection device comprises a wire mesh device. In yet another embodiment, the device includes an endoscope with a built-in ultrasound emitting transducer that is used to measure the position of the cell collection device within the body.
[Selection] Figure 1

Description

  The present invention relates generally to the field of medical devices. More specifically, the present invention relates to a cytology device for collecting cell specimens from a mammalian body and a method for collecting those specimens.

  This application claims the benefit of US Provisional Patent Application No. 60 / 479,709, filed Jun. 19, 2003. This application is a continuation-in-part of US patent application Ser. No. 10 / 699,487, filed Oct. 31, 2003, “Medical device assembly including handle and handle for a medical device”.

(Background technology)
Recent developments in methods and devices that minimize invasiveness have revolutionized medical practice. These methods and devices allow clinicians to perform a variety of procedures with minimal trauma to the patient. In order to collect cell samples from the mammalian body along this line, there is a need for a cell collection device that employs a technique that minimizes invasiveness and its use.

  Many of the existing cytology devices suffer from one or more problems. For example, in some prior art, contamination of the cytology device due to the use of an open needle lumen is a problem when collecting cell specimens. This is due to the inadvertent collection of undesirable substances as the open needle lumen travels through the body during the procedure. Other prior art techniques make it difficult to collect a suitable specimen. This is believed to be due to the use of a small diameter needle for sample collection without the aid of a cell collection device such as a brush, balloon or wire mesh device. In addition, in the prior art, it may be difficult to maneuver the cytology device to an accurate position within the body. This often occurs due to the lack of a guidance system that indicates where in the body the cell collection device is located.

  It would be beneficial to provide a minimally invasive cytology device and method of use that guards one or more of the above and other problems.

  The present invention provides a cytology apparatus employing a technique that minimizes invasiveness in order to collect a cell specimen from a mammalian body, and a method for using the same.

  In certain embodiments, the medical device includes a needle having a proximal end, a distal end, and an inner lumen extending from the proximal end to the distal end. A stylet having a proximal end and a distal end is also included. The stylet can be inserted into and removed from the inner lumen of the needle, and at least a portion of the stylet will block the inner lumen of the needle when the cell sample is cut. Yes. Further included is a cell collection device having a proximal end and a distal end. The cell harvester can be inserted into the inner lumen of the needle once the stylet has been removed from the inner lumen of the needle. The proximal end of the cell collection device can be extended beyond the tip of the needle to collect a cell sample.

  In another embodiment, a medical device for collecting a cell sample from a mammalian body includes an endoscope with a transducer. The endoscope defines a working lumen. The device also includes a member having a proximal end, a distal end, and an inner lumen that extends into the working lumen of the endoscope. A cell collection device having a proximal end and a cell collection tip is also included. The cell collection device can be inserted into the inner lumen of the member, and the tip of the cell collection device can be extended beyond the tip of the member to collect a cell sample. The transducer emits ultrasound to measure the position of the cell collection device within the mammal using ultrasound.

  In yet another embodiment, a method for collecting a cell specimen from a mammalian body is disclosed. An apparatus is provided that includes a needle having a proximal end, a distal end, and an inner lumen extending from the proximal end to the distal end. A stylet having a proximal end and a distal end is also included. Also included is a cell collection device having a proximal end and a cell collection tip. The stylet is inserted into the inner lumen of the needle so that a portion thereof blocks the inner lumen of the needle. When a region within the mammalian body is cut, the stylet is removed from the inner lumen of the needle. The cell collection device is inserted into the inner lumen of the needle so that its tip extends beyond the needle tip. Eventually, when a cell sample is collected from the mammalian body using the cell collection device, the tip of the cell collection device is drawn into the inner lumen of the needle.

  In another embodiment, a method for collecting a cell specimen from a mammalian body is also disclosed. An apparatus is provided that includes an endoscope that defines a working lumen and in which a transducer is contained. The device includes a member having a proximal end, a distal end, and an inner lumen that extends into the inner lumen of the endoscope. Also included is a cell collection device having a proximal end and a cell collection tip that extends into the inner lumen of the member. The working lumen of the endoscope is inserted into the body of a mammal, and the tip of the cell collection device extends beyond the tip of the member. Ultrasound is emitted from the transducer of the endoscope, reflected by the cell collection device, and received using the transducer of the endoscope. Thus, the position of the cell collection device within the mammal is measured.

  Hereinafter, some embodiments of the present invention will be described in detail. The embodiments described and illustrated herein are merely representative in nature and are not intended to limit the scope of the invention in any way. Rather, the description of these embodiments is merely to assist one of ordinary skill in the art to embody and use the present invention.

  1, 1A, 2-3, 3A, 3B, 4, 4A, and 4B illustrate a device 10 for collecting cell specimens from a mammalian body according to an embodiment of the present invention. In this embodiment, the device 10 includes an inner handle member 12 having a proximal end 14 and a distal end 16. The first outer handle member 18 is slidably disposed on the proximal end 14 of the inner handle member 12. The second outer handle member 20 is slidably disposed on the tip 16 of the inner handle member. An elongated sheath 22 is attached to the inner handle member 12 and extends beyond the tip 16 of the inner handle member 12 in the axial direction. As used herein, the term "axial direction" means that one member is around an axis of another member, in the direction of an axis, on an axis, or along an axis. Refers to being disposed, and is limited to the fact that one member is disposed around, in the direction of, on, or along the central axis of another member. It is not a thing. The sheath 22 defines a see-through membrane 24.

  A needle 26 is attached to the first outer handle member 18 and is at least partially disposed within the see-through membrane 24. In other embodiments, a first member having a generally tubular end or other non-sharp shaped end is used in place of the needle. The needle 26 can perform suction. Needle 26 can be made of a variety of materials including steel and other types of metals. Needle 26 defines a needle lumen 28 and has a proximal end 31 and a distal end 33. A stylet 30 having a proximal end 35 and a sharp tip 37 is slidably disposed within the needle lumen 28, which is entirely outside the needle lumen 28 at each point during the procedure. Or partially disposed within the needle lumen 28, or entirely disposed within the needle lumen 28. In other embodiments, the tip of the stylet is not sharp but has various shapes such as a rounded shape. The stylet 30 includes a solid rod. When the stylet 30 is inserted into the needle lumen 28, the outer periphery 39 of the stylet 30 fits the inner diameter 41 of the needle lumen 28. The sharp tip 37 of the stylet 30 is designed to extend beyond the tip 33 of the needle about a centimeter in order to cut out a region within the mammalian body. The specimen can be cut out. In other embodiments, the tip 37 of the stylet 30 can extend from the needle tip 30 by various lengths. In yet another embodiment, the tip 37 of the stylet 30 is not adapted to extend beyond the needle tip 33 to cut tissue and its sole purpose is to occlude the needle lumen 28 during the cutting procedure. That is. In the above embodiments, needle 26 or other devices and / or methods known in the art may be used to cut an area within the mammal.

  A significant advantage of the present invention is that undesirable fluids and materials do not contaminate the needle lumen 28 at the needle tip 33 when cutting the cell specimen. This is because the outer periphery 39 of the stylet 30 is closely aligned with the inner diameter 41 of the needle lumen 28 so that the stylet 30 blocks the needle lumen 28. The stylet 30 can be made of one or more of steel, metal, and nitinol. In other embodiments, the stylet can be made of a variety of materials in a variety of shapes, including rectangular and polygonal. The stylet 30 extends in the axial direction beyond the second outer handle member 20 and into the see-through membrane 24. As will be described later, the handle 49 moves the stylet 30 and the needle 26 in the axial direction. In addition to the preferred embodiment described above, the handle 49 may include a variety of types including finger loop type handles, pin-vise type handles, and half finger loop type handles.

  FIG. 1 shows a closed state of the device 10 according to this embodiment of the invention. That is, the first and second outer handle members 18, 20 are fully pushed over the corresponding portions of the inner handle member 12. In this state of this embodiment, the first and second outer handle members 18, 20 enclose the inner handle member 12.

  FIG. 2 shows the device 10 in an open state. In this state, the first and second outer handle members 18, 20 are both retracted from their respective positions relative to the inner handle member shown in FIG. In this open state, the inner handle member 12 is exposed. When the apparatus 10 is changed from the closed state shown in FIG. 1 to the open state shown in FIG. 2, the relative positions of the various components change. For example, since the sheath 22 is attached to the inner handle member 12, when the second outer handle member 20 is moved along the inner handle member 12, the sheath 22 extends axially beyond the tip of the second outer handle member 20. The length that extends to the length changes accordingly. Further, since the needle 26 is attached to the first outer handle member 18, when the first outer handle member 18 is moved along the inner handle member 12, the position of the needle 26 with respect to the sheath 22 changes. Somehow this movement changes the length of the needle 26 that extends axially beyond the tip of the sheath 22. Comparing FIGS. 1 and 2, when the device 10 is in the closed state (FIG. 1), the needle 26 can extend axially beyond the distal end of the sheath 22, but the handle is in the open state (FIG. 2). In the sheath 22 can completely fit into the sheath 22.

  3 and 4 are cross-sectional views of the device 10 in a closed state and an open state, respectively. These drawings, including the enlarged views shown in FIGS. 3A, 3B, 4A, 4B, illustrate various mechanisms for controlling the relative positions of various components using the apparatus 10. FIG.

  Inner handle member 12 defines a handle lumen 32 that contains various portions of various components of device 10. The distal end side cap 34 closes the handle lumen 32 at the distal end 16 of the inner handle member 12. The distal end side cap 34 may be integrated with the inner handle member 12 or may be a member attached separately. The distal end cap 34 defines first and second distal end cap stoppers 36, 38. These stoppers 36 and 38 are disposed at the ends of the first and second distal guide grooves 40 and 42 defined by the inner handle member 12. The second outer handle member 20 has a distal collar 44 that defines first and second protrusions 46, 48. When the second outer handle member 20 is slid along the inner handle member 12, the protrusions 46 and 48 move along the first and second distal guide grooves 40 and 42, respectively. Eventually, the distal end side cap stoppers 36 and 38 abut against the protrusions 46 and 48 and prevent the second outer handle member 20 from moving further in the distal direction. As in the case of the distal end side cap 34, the distal end side collar 44 may be a component that is integral with the second outer handle member 20, or may be a member that is attached separately. In addition, the inner handle member 12 may have fewer or more tip side guide grooves, and the device 10 serves as a mechanism for restricting the movement of the second outer handle member 20 along the inner handle member 12. Any suitable alternative mechanism may be included.

  The proximal cap 50 closes the handle lumen 32 at the proximal end 14 of the inner handle member 12. The proximal cap 50 defines first and second proximal cap stoppers 52, 54. These stoppers 52, 54 are located at the ends of the first and second proximal guide grooves 56, 58 defined by the inner handle member 12. The first outer handle member 18 has a proximal collar 60 that defines first and second protrusions 62, 64. When the first outer handle member 18 is slid along the inner handle member 12, the protrusions 62 and 64 move along the first and second proximal guide grooves 56 and 58, respectively. Eventually, the proximal cap stoppers 52 and 54 abut against the protrusions 62 and 64 to prevent the first outer handle member 18 from moving further in the proximal direction. As in the case of the distal end side cap 34 and the collar 44, the proximal end side cap 50 and the collar 60 may be an integral component with the inner handle member 12 and the first outer handle member 18, respectively, or may be configured as separate members. It may be attached to the element. Also, the inner handle member 12 may have fewer or more proximal guide grooves, and the device 10 generally restricts movement of the first outer handle member 18 along the inner handle member 12. Any alternative mechanism suitable as a mechanism to do this may be included.

  The inner handle member 12 can also have a stopper 66 between the first outer handle member 18 and the second outer handle member 20. The stopper 66 separates an area in which the first and second outer handle members 18, 20 can move along the inner handle member 12. The stopper 66 also provides a physical barrier that prevents the outer handle members 18, 20 from moving further along the inner handle member 12. When the stopper 66 is provided, the stopper 66 may be an integral part of the inner handle member 12 or may be a member attached separately. As can be seen in FIG. 2, the stopper 66 can comprise a circumferential protrusion defined by the inner handle member 12.

  The device 10 may further have various adaptive structures that facilitate operation of the device 10. For example, as can be seen from FIG. 2, the inner handle member 21 can be provided with a scale 70 of the first series 68. If provided, the scale of the series 68 can be disposed on a portion of the inner handle member 12 that moves along the first outer handle member 18. If comprised in this way, each scale 70 of the series 68 will be made to respond | correspond to the predetermined position with respect to the front-end | tip of the sheath 22 attached to the inner side handle member 12 of the needle | hook 26 attached to the 1st outer side handle member 18. be able to. Further, each scale 70 of the series 68 can correspond to a predetermined length in which the needle 26 extends in the axial direction beyond the distal end of the sheath 22.

  Further comparison of FIGS. 1 and 2 illustrates an example of the operation of the scale 68 of this series 68. In the open state shown in FIG. 2, the most proximal scale that can be seen on the scale 68 of the series 68 is “0”. In this state, the needle 26 does not extend beyond the distal end of the sheath 22. Accordingly, in this example, the scale “0” corresponds to the length of the needle 26 extending in the axial direction beyond the distal end of the sheath 22 being zero. In FIG. 1, the handle is fully closed. To change from the open state shown in FIG. 2 to this state, the user advances the first outer handle member 18 so as to cover all the scales 70 of the series 68. As the user moves the first outer handle member 18 along the inner handle member 12, the first outer handle member 18 continuously passes through the scale 68 of the series 68. Each scale 70 can correspond to the length that the needle 26 extends beyond the tip of the sheath 22. When the first outer handle member 18 is fully covered so as to cover the inner handle member 12 and reaches the stopper 66, all the scales 70 of the series 68 are covered. As shown in FIG. 1, this state corresponds to the maximum length that the needle 26 extends beyond the tip of the sheath 22. Thus, by moving the tip of the first outer handle member 18, such as the collar 60, to a specific scale on the series 68 scale 70, the user of the device 10 advances the needle 26 to the desired position relative to the sheath 22. be able to.

  The device 10 may further have a second series 72 scale 74. Similar to the first series 68 scale 70, the second series 72 scale 74 can be disposed on the inner handle member 12. A scale 74 of the second series 72 can be disposed on the portion of the inner handle member 12 that moves the second outer handle member 20 along. If comprised in this way, each scale of the scale 74 of the 2nd series 72 is the sheath 22 attached to the inner side handle member 12, and the front-end | tip of the 2nd outer side handle member 20 which can be attached to another medical device. It corresponds to a predetermined length that extends in the axial direction beyond.

  Further comparison between FIG. 1 and FIG. 2 will explain an operation example of the scale 74 of the series 72. In the open state shown in FIG. 2, the most proximal scale that can be seen on the scale 72 of the series 72 is “0”. The scale “0” can correspond to a specific length in which the sheath 22 extends beyond the tip of the second outer handle member 20. When the second outer handle member 20, and thus the entire device 10, is used with another medical device having a working lumen such as an endoscope, the scale “0” extends axially beyond the tip of the other medical device. This can correspond to the length of the extending sheath 22 being zero. For example, a “0” scale may indicate that the sheath 22 does not extend at all out of the working lumen of the attached medical device. When the second outer handle member 20 is moved along the inner handle member 12, it passes through a series 72 of continuous scales 74. Each scale 74 of the series 72 can correspond to a predetermined length in which the sheath 22 extends beyond the tip of the second outer handle member 20. Further, when the second outer handle member 20 is used with another medical device, each scale 74 can correspond to a predetermined length that the sheath extends axially beyond the tip of the medical device. When the second outer handle member 20 is fully advanced to cover the inner handle member 12 and reaches the stopper 66, the closed state shown in FIG. 1 is reached, all the scales 74 of the series 72 are covered. Can indicate the maximum length that extends axially beyond the tip of the second outer handle member 20 or the tip of the attached medical device.

  The first outer handle member 18 may have an adaptive structure that facilitates operation of the device 10. For example, the first outer handle member 18 can define an enlarged diameter 76 that provides a rest position for the user's finger or thumb. The enlarged diameter portion 76 is an outer peripheral portion of the first outer handle member 18 and has a larger diameter than other portions of the first outer handle member 18. Further, the grip insert 78 may be attached to the first outer handle member 18 or may be defined by the first outer handle member 18. The grip insert 78 provides a surface that facilitates handling of the device 10. The grip insert 78 may be formed of the same material as the first outer handle member 18, such as plastic, or may be another material such as rubber or other polymer material.

  The device 10 can be used with other medical devices. In some embodiments, it may be desirable to allow the device 10 to be attached to another medical device. The second outer handle member 20 defines an adaptive structure that facilitates attachment of the device 10 to another medical device. For example, the second outer handle member 20 can define a connector 80. The connector 80 can structurally interact with another connector of another medical device to which the device 10 is to be attached. This interaction between the connector 80 and another connector of the medical device may be a mating connection or a locking connection. Any suitable connector may be used as the connector 80, and a luer connector is an example of a particularly suitable connector. Other suitable types of connectors include clamp connectors, engagement member connections such as thumb screws, and the like.

  Device 10 may include additional components that facilitate relative movement of the inner components of the device. Examples of such additional components are shown in FIGS. 3A, 3B, 4A, 4B. An inner guide tube 82 can be placed around the needle 26 in the handle lumen 32. The inner guide tube 82 is a tubular member that surrounds the needle 26. The inner guide tube 82 may define a collar 84 that is disposed near the stopper 66 of the inner handle member 12. The inner guide tube 82 can also be attached to the inner handle member 12. Further, as can be seen in FIG. 3A, the position of the inner handle member 12 can be secured by surrounding the needle 26, the collar 84 being positioned adjacent to the stopper 66, or both. As can be seen in FIG. 3B, the outer guide tube 86 can also be disposed around a portion of the inner guide tube 82 in the handle lumen 82. In this embodiment, the outer guide tube 82 is attached to the first outer handle member 18 so that sliding the first outer handle member 18 along the inner handle member 12 will move along the inner guide tube 82. To slide. The outer guide tube 86 may be attached to the first outer handle member 18 in any suitable manner. In this embodiment, the outer guide tube 86 defines a flare 88 at the proximal end. The flare 88 is disposed in the recess 90 of the first outer handle member 18. The access port 92 is disposed at the proximal end of the first outer handle member 18 and adjacent to the flare 88 to effectively lock the outer guide tube 86 in place relative to the first outer handle member 18. ing. This attachment may be done with an adhesive or other suitable coupling mechanism.

  Providing the inner guide tube 82 and the outer guide tube 86 can prevent components in the handle lumen 32 from buckling while the device 10 is repeatedly moved between the open and closed states.

  Access port 92 provides access to needle lumen 28 from the external environment of device 10. The access port 92 may be formed integrally with the first outer handle member 18 or may be a member attached separately.

  The stylet 30 is slidably disposed in the access port 92. The stylet 30 includes a cap 96 at the proximal end of the first outer handle member 18 that is attached to the proximal end 35 of the stylet to facilitate insertion and removal from the access port 92. The cap 96 can interact with the throat 94 defined by the access port 92 to guide and / or limit movement of the stylet 30 into the access port 92. Further, the cap 96 may define an adaptive structure that fixes the position of the cap 96 relative to the access port 92. For example, the cap 96 may define a notch 98 that enters the groove 100 defined by the access port 92. This interaction between notch 98 and groove 100 prevents rotation and axial movement of stylet 30 attached to cap 96.

  5 and 6 illustrate a handle 110 according to another embodiment of the present invention. The handle 110 of this embodiment is the same as the handle of the previously described embodiment, except as described in detail below. Accordingly, the same reference numbers in FIGS. 5 and 6 refer to the same features and / or components of the embodiments described above and shown in FIGS. 1-3, 3A, 3B, 4, 4A, 4B. FIG. 5 shows a closed state of the handle 110 according to this embodiment.

  In this embodiment, the second outer handle member 120 defines a hole 111. The hole 111 is disposed on the second outer handle member 120 so as to be disposed on a portion of the series of scales 174 disposed on the inner handle member 12. The dimensions and shape of the hole 111 may vary, but the hole 111 must be capable of indicating one or more scales 174 in a significant manner.

  In this embodiment, the second outer handle member 120 further includes means for fixing the axial position of the inner handle member 112 relative to the second outer handle member 120. Any means may be used as long as it is suitable for fixing the axial position between the two slidably engaged components. For example, a selectively engageable member that extends through the thickness of the second outer handle member 120 can be used as a means for securing. The selectively engageable member can be withdrawn from or advanced through the wall thickness to engage the inner handle member 112. When the wall thickness is penetrated and arranged so as to contact the inner handle member 112, the axial position of the inner handle member 112 with respect to the second outer handle member 120 is fixed. That is, since the member that can selectively engage with the inner handle member 112 is in contact, the second outer handle member 120 is prevented from moving further along the inner handle member 112 in the axial direction.

  FIG. 5 shows a thumbscrew 113 which is a selectively engageable member suitable for use as a means for securing. The thumbscrew 113 is easily advanced through the wall thickness of the second outer handle member 120 to contact the inner handle member 112 and the relative axial direction between the inner handle member 112 and the second outer handle member 120. The position can be fixed. The second outer handle member 120 is provided with a thread that interacts with a complementary thread of the thumbscrew 113 so that the thumbscrew 113 can enter and exit the wall thickness of the second outer handle member 120. Yes.

  In this embodiment, a slidable member 115 is further disposed on the inner handle member 112. The slidable member 115 may be a locking member that is slidably disposed on the inner handle member 112. The slidable member 115 may have an adaptive structure that can lock the slidable member 115 in any of a plurality of positions on the inner handle member 112. For example, the slidable member 115 may have means for securing as described above with respect to the second outer handle member 120, such as a thumbscrew 119. The slidable member 115 is a movable stopper that restricts the movement of the first outer handle member 118 along the inner handle member 112. Thus, this stopper limits the movement of the needle 126 attached to the first outer handle member 118 relative to the sheath. By locking the slidable member 115 in a desired position along the inner handle member 112, indicated by the scale 170, the user of the handle 110 sets the maximum length that the needle 126 can extend beyond the sheath 122. can do. In this way, the user moves the first outer handle member 118 between the fully retracted position and the position where the slidable member 115 is locked along the adjustment width of the inner handle member 112. be able to. This adjustment width is a limited portion of the inner handle member 112 that can be moved along the first outer handle member, and the exact length of the adjustment width is at a position where the slidable member 115 is locked. It depends on it. In other words, the selected position of the slidable member 115 depends on the desired maximum stretch length of the needle 126 relative to the sheath 122.

  In order to facilitate positioning of the slidable member 115 at a desired location on the inner handle member 112, the slidable member 115 allows the portion of the underlying inner handle member 112 that includes one or more scales 170 to be visible. A hole 117 may be defined. The hole 117 may be of any suitable size, shape, and configuration, but the portion of the underlying inner handle member may appear in a significant manner such that at least one scale 170 is fully visible. Must be. As shown in FIGS. 5 and 6, the slidable member 115 is disposed circumferentially around the inner handle member 112 and between the first outer handle member 118 and the second outer handle member 120. You may have a color.

  7 and 7A illustrate a handle 210 according to another embodiment of the present invention. The handle 210 according to this embodiment is the same as the handle of the first embodiment described above, except as described in detail below. Accordingly, the same reference numbers in FIGS. 7 and 7A refer to the same features and / or components of the embodiments described above and shown in FIGS. 1-3, 3A, 3B, 4, 4A, 4B. FIG. 7 shows the opened state of the handle according to this embodiment.

  In this embodiment, the inner handle member 212 defines a first guide groove 221 and a second guide groove 223. One or both of the guide grooves 221, 223 can be located at separate positions on the handle member where other components such as the outer handle member 218, 220 or other slidably mounted members are located. A plurality of stoppers 225 are defined. In this embodiment, the stopper 225 comprises a protrusion defined by the inner handle member 212 and disposed in the guide grooves 221, 223. The stopper 225 may be a separately attached member disposed in the guide grooves 221 and 223.

  The stopper 225 temporarily stops the sliding motion of the component on the inner handle member 212, but does not completely stop such motion. Rather, the stopper 225 merely provides resistance, and additional force can overcome this resistance and allow the component to continue to slide along the inner handle member 212. . As the slidable component is moved along the inner handle member 112, the slidable component can interact with the stopper 225 to generate a sound. This generation of sound can provide the operator of the handle 210 with additional feedback that indicates the relative positions of the various components of the handle 210. The slidable component that interacts with the stopper 225 in this manner may be one or both of the outer handle members 218, 220, as described above in connection with the embodiment shown in FIGS. Any other slidable component disposed on the inner handle member 212, such as a slidable member.

  The stopper 225 may be disposed on the inner handle member 212 in any suitable arrangement and configuration. As can be clearly seen in FIG. 7, the stopper 225 may be disposed adjacent to each scale 270 of a series of scales 268 disposed on the inner handle member 212. Alternatively, the first set of stoppers 225 may be disposed on a portion of the inner handle member 212, and the second set of stoppers 225 may be disposed on the second portion of the inner handle member 212. For example, as shown in FIG. 7, a first set of stoppers 225 is disposed adjacent to a scale 270 of the first series 268 and a second set of stoppers 225 is positioned on a scale 274 of the second series 272. You may arrange | position adjacent to.

  In this embodiment, the inner handle member may define any number of guide grooves where appropriate, and a stopper 225 may be provided in one or more guide grooves.

  8, 8A, 9-10, 10A, 10B, 11, 11A, 11B, except that the stylet 30 is withdrawn from the needle lumen 28 and the brush 300 is inserted into that position in the needle lumen 28. The apparatus is the same as that shown in FIGS. 1, 1A, 2-3, 3A, 4, 4A, and 4B. The brush 300 is a cell collection device used to collect a cell sample cut by the stylet 30. In other embodiments, different cell collection devices such as inflatable balloons, wire mesh devices, or other types of collection devices may be used. When inserted into the needle lumen 28, the brush 300 may be partially disposed within the needle lumen 28, or entirely within the needle lumen 28, at various times during the procedure. . The brush 300 includes an elongated member 324 having a proximal end 312 and a distal end 318 and a plurality of bristles 324 attached to a location 330 near the distal end 318 of the elongated member 306. The elongate member 306 includes a wire 336. Wire 336 can be made of a variety of materials including steel, other types of metals, and nitinol. The wire 336 is twisted so as to surround the plurality of bristles 324, and the plurality of bristles 324 are coupled to the wires. The bristles 324 can be made of a variety of materials including nylon, brass, steel, carbon, polymers, or other types of metals. The brush 300 extends axially beyond the second outer handle member 20 and into the see-through membrane 24. The distal end 318 of the elongate member 306 terminates with a steel cap 342. In other embodiments, the elongate member 306 terminates in a loop, ball tip, conical tip, umbrella tip, or other type of tip, which can be a variety of materials including various types of metals and scissors. Can be made with. As discussed above, the handle 49 can move the brush 300 and the needle 26 in the axial direction. In addition to the preferred embodiment described above, the handle 49 may have a variety of types including a finger loop type handle, a pin-vise type handle, and a half finger loop type handle.

  The brush 300 is slidably disposed in the access port 92. The brush 300, like the stylet 30, has a cap 304 at the proximal end of the first outer handle member 18 that is attached to the elongate member 306, inserted into the access port 92, and then Make it easy to remove. The cap 304 interacts with the throat 94 defined by the access port 92 to guide and / or limit movement of the brush 300 into the access port 92. Further, the cap 304 can define a conforming structure that secures the position of the cap 304 relative to the access port 92. For example, the cap 304 can define a notch 98 that enters the groove 100 defined by the access port 92. This interaction between the notch 98 and the groove 100 can prevent rotational movement of the cap 304 and the attached brush 300.

  Initially, the distal end 318 of the brush is placed in the inner lumen 28 of the needle. The cap 304 is then extended axially toward the handle 49 in order to extend the brush tip 318 to the outside of the needle inner lumen 28. Once the brush tip 318 extends out of the inner lumen 28 of the needle, the cap 304 is moved back and forth in the axial direction to collect a cell sample using the bristles 324 near the brush tip 318. Once the cell sample is collected, the cap tip 318 is retracted into the inner lumen 28 of the needle to prevent the sample from being contaminated by undesirable liquids or materials when the sample is removed from the body. Is retracted in the direction away from the handle 49 in the axial direction. The cap 304 can abut the tip 33 of the needle to prevent the specimen from being contaminated. A mark or marker may be used near the proximal end 312 of the brush 300 to indicate to the operator when the tip 318 of the brush 300 or other cell collection device has extended beyond the needle tip 33.

  FIGS. 12, 12A, 12B, 12C replace the brush 300 of the above embodiment with an inflatable and deflated balloon that serves as a cell collection device used to collect cell specimens cut with the stylet 30. FIG. Figure 3 shows another embodiment that is provided. The balloon 350 is connected to a tube 351 having an inner lumen 352, through which air or liquid can be introduced to fill the balloon 350. The assembly of the tube 351 and balloon 350 enters the see-through lumen 24 through the inner handle 12 and further extends to the inner lumen 28 of the needle 26. Screw the cap 354 at the end of the tube 351 to the position where the tube is locked in place. The balloon 350, when deflated, fits within the inner lumen 28 of the needle 26, and when outside the inner lumen of the needle 28, the balloon 350 is inflated to collect a cell sample in the mammalian body. FIG. 12B shows the balloon 350 and tube 351 assembly with the balloon 350 deflated. FIG. 12C shows the balloon 350 and tube 351 assembly with the balloon 350 inflated. The outer surface 356 of the balloon 350 is rough so that the cellular tissue can be scraped to collect the cell specimen when inflated. The balloon is polyethylene terephthalate. A cap 354 is slidably disposed at the proximal end of the first outer handle member 18 and is attached to the assembly of the balloon 350 and the tube 351 to control the axial movement of the balloon 350. A cap 354 is used to control the axial movement of the balloon 350, and the balloon 350 is initially deflated into the inner lumen 28 of the needle 26 to obtain a cell sample. After being slid out of the inner lumen 28 and inflated to obtain a cell sample, it is pulled back into the inner lumen 28 of the needle 26.

  FIG. 13 illustrates a medical device assembly 352 according to another embodiment of the present invention. The medical instrument assembly 352 includes a handle 356 according to any of the embodiments of the present invention. The handle 356 is attached to the medical device 375. The medical device 375 defines a working lumen 377. The sheath 366 of the handle 356 is attached to the inner handle member of the handle 356 and extends axially beyond the distal end of the inner handle member and into the working lumen 377 of the medical device 375. Attachment of the handle 356 to the medical device 375 may be performed in any suitable manner, including placing the connector on the second outer handle member 360 side as described above.

  A medical instrument 375 suitable for use in the medical instrument assembly 352 according to the present invention comprises an endoscope. Any of the above embodiments includes an endoscope incorporating a transducer 380 that emits a series of waves or pulses. Waves or pulses propagate through body tissue in the mammalian body at a rate determined by the physical properties of the tissue. The wave or pulse is then reflected back to the transducer when it encounters tissue or other mass that is difficult for sound waves to pass through. The transducer 380 detects the reflected wave and converts it into an electrical signal for image processing in order to determine the position of the tissue or other mass where the wave is reflected. In this way, the transducer 380 can measure the position within the body of a cell collection device such as a balloon or brush. In one embodiment, in order to easily reflect ultrasonic waves, the cell collection device includes a hollow wire having a proximal end and a distal end, and a plurality of bristles connected to locations near the distal end of the hollow wire. It may be. The recessed wire supports the reflection of ultrasound. In another embodiment, the bristles may be steel or other material that facilitates reflecting ultrasonic waves. Using this device and method makes it easier for the operator or physician to guide the cell collection device in the body during the procedure.

  A number of methods can be employed to collect cell specimens from the mammalian body using any of the embodiments disclosed above. FIGS. 14-14D disclose the steps of one such method using the apparatus of FIGS. 1-4B and FIGS. 8-11B. As shown in FIG. 14, the stylet 30 is inserted into the inner lumen 28 of the needle 26 with its sharp tip 37 extending beyond the tip 33 of the needle 26. The stylet 30 closes the inner lumen 28 of the needle 26 to avoid contamination during specimen cutting. The sharp tip 37 of the stylet 30 is then used by moving a cap 96 attached to the proximal end 35 of the stylet 30 back and forth in the axial direction to cut out a region within the mammalian body, such as a cyst. . In other embodiments and / or methods, the tip 37 of the stylet 30 is not sharp and may not be used for cutting, limiting the purpose of closing the inner lumen 28 of the needle 26 during the cutting procedure. . In these embodiments, the needle 26 or other device and / or method known in the art is used to cut an area within the mammal. Next, as shown in FIG. 14A, the stylet 30 is withdrawn from the inner lumen 28 of the needle 26. At this point, suction can also be performed through the needle 26. Next, as shown in FIG. 14B, the cell collection device 300 is inserted into the inner lumen 28 of the needle 26. In other embodiments, the device includes an endoscope with an ultrasound emitting transducer that is used to measure the position of the cell collection device in the body. Next, as shown in FIG. 14C, the tip 318 of the cell collection device 300 is extended until the cell collection device 300 extends beyond the tip 33 of the needle 26. Next, the cell sample is collected using the cell collection device 300 while moving the cap 304 attached to the proximal end 312 of the cell collection device 300 back and forth in the axial direction. Finally, as shown in FIG. 14D, the tip 318 of the cell collection device 300 is retracted into the inner lumen 28 of the needle 26 to avoid contamination of the collected sample. The device is then removed from the body.

  FIG. 15 illustrates, in flowchart form, another method for obtaining a cell sample from a mammalian body. First, in step 400, an apparatus is prepared. The apparatus includes an endoscope that defines a working lumen and includes a transducer. In addition, the apparatus includes a first member that includes a proximal end, a distal end, and an inner lumen, the first member extending into the working lumen of the endoscope. The first member is preferably a needle. The device also includes a cell collection device having a proximal end and a cell collection tip that extends into the inner lumen of the first member. The endoscopic working lumen is inserted into the mammal at step 410. Next, in step 420, the tip of the cell collection device is extended so as to exceed the tip of the first member. In step 430, ultrasound is emitted from the transducer of the endoscope. At step 440, the ultrasound is reflected to the cell harvester for its material and composition and received at step 450 with the transducer of the endoscope. The transducer converts this wave into an electronic signal for image formation. Finally, in step 460, the position of the cell collection device in the mammalian body is measured from the transformed image formed from the ultrasound received by the transducer.

  The foregoing detailed description provides representative embodiments of the invention and includes the best mode for carrying out the invention. These embodiments are only intended to be examples of the invention and are not intended to limit the scope of the invention in any way.

1 is a perspective view of an apparatus for collecting a cell sample from a mammalian body, according to an embodiment of the present invention using a stylet to cut the cell sample. FIG. FIG. 2 is an enlarged view of a part of the apparatus shown in FIG. 1. It is a perspective view which shows the state in an open form of the apparatus shown in FIG. It is a longitudinal cross-sectional view of the apparatus shown in FIG. FIG. 4 is an enlarged view of a part of the apparatus shown in FIG. 3. FIG. 4 is an enlarged view of a part of the apparatus shown in FIG. 3. It is a longitudinal cross-sectional view of the apparatus shown in FIG. FIG. 5 is an enlarged view of a part of the apparatus shown in FIG. 4. FIG. 5 is an enlarged view of a part of the apparatus shown in FIG. 4. FIG. 6 is a perspective view of an apparatus according to another embodiment of the present invention. FIG. 6 is a cross-sectional view of the device shown in FIG. 5 taken along line 6-6. FIG. 6 is a perspective view of an apparatus according to another embodiment of the present invention. It is sectional drawing which follows the 7A-7A line of the apparatus shown in FIG. FIG. 2 is a perspective view of an apparatus for collecting cell specimens from a mammalian body according to an embodiment of the invention using a cytology brush to collect specimens cut by the apparatus of FIG. FIG. 9 is an enlarged view of a part of the apparatus shown in FIG. 8. It is a perspective view which shows the state which exists in the open form of the apparatus shown in FIG. It is a longitudinal cross-sectional view of the apparatus shown in FIG. It is a one part enlarged view of the apparatus shown in FIG. It is a one part enlarged view of the apparatus shown in FIG. It is a longitudinal cross-sectional view of the apparatus shown in FIG. FIG. 12 is an enlarged view of a part of the apparatus shown in FIG. 11. FIG. 12 is an enlarged view of a part of the apparatus shown in FIG. 11. 1 is a perspective view of an apparatus for collecting cell specimens from a mammalian body according to an embodiment of the invention using a cytological balloon for specimen collection. FIG. FIG. 13 is an enlarged view of a part of the apparatus shown in FIG. 12. FIG. 13 is a front view of the balloon assembly forming part of the apparatus shown in FIG. 12 in a deflated state. FIG. 13 is an inflated front view of a balloon assembly that forms part of the apparatus shown in FIG. 12. FIG. 6 is a perspective view of an apparatus according to another embodiment of the present invention. 1 is a perspective view of an apparatus at a stage of a method for collecting a cell specimen according to an embodiment of the present invention. FIG. Figure 2 is a perspective view of the device at another stage of the method. FIG. 14B is a perspective view of the apparatus of FIG. 14A with the stylet replaced with a cytological brush at another stage of the method. FIG. 14B is a perspective view of the apparatus of FIG. 14B at another stage of the method. FIG. 14C is a perspective view of the apparatus of FIG. 14C at another stage of the method. 6 is a flowchart illustrating a method for collecting a cell specimen according to another embodiment of the present invention.

Claims (107)

In medical equipment:
A needle having a proximal end, a distal end, and an inner lumen extending from the proximal end to the distal end;
A stylet having a proximal end and a distal end, wherein the stylet is adapted to be inserted into and withdrawn from the inner lumen of the needle, wherein at least a portion of the stylet is a cell sample A stylet that is configured to occlude the inner lumen of the needle when it is cut;
A cell collection device having a proximal end and a distal end, wherein the stylet is inserted into the inner lumen of the needle when the stylet is withdrawn from the inner lumen of the needle; A medical device comprising: a tip, a cell collection device configured to extend beyond the tip of the needle to collect the cell sample.   The medical device according to claim 1, wherein the cell collection device includes an elongated member having a proximal end, a distal end, and a plurality of bristles.   The medical device of claim 1, wherein the tip of the cell collection device terminates in one of a cap, a ball tip, a conical tip, an umbrella tip, and a loop.   4. The medical device of claim 3, wherein one of the cap, ball tip, conical tip, umbrella tip, and loop is made of one or more of steel, metal, and solder. .   The medical device according to claim 2, wherein the elongate member comprises a wire, the wire being twisted to wrap around the plurality of bristles.   6. The medical device of claim 5, wherein the wire is made of one or more of steel, metal, and nitinol.   The medical device according to claim 2, wherein the tip of the elongate member is adapted to be retracted into the inner lumen of the needle after collection of the cell specimen.   The medical device according to claim 1, wherein the needle is made of one or more of steel and metal.   The medical device according to claim 2, wherein the plurality of bristles are made of one or more of nylon, brass, stainless steel, metal, carbon, and polymer.   The medical device according to claim 1, wherein the needle is adapted to perform suction.   The medical instrument according to claim 1, further comprising a handle adapted to move the cell collection device and the needle in an axial direction. The handle
An inner handle member having a proximal end and a distal end;
A first outer handle member slidably disposed on the inner handle member;
An elongate sheath attached to the inner handle member and extending axially beyond the tip of the inner handle member, defining a see-through membrane, the needle being attached to the first outer handle member The medical device of claim 11, comprising an elongate sheath attached and disposed within the see-through membrane. The handle
An inner handle member having a proximal end and a distal end and defining a handle lumen;
A first outer handle member slidably disposed on the proximal end of the inner handle member;
A second outer handle member slidably disposed on the tip of the inner handle member;
An elongate sheath attached to the inner handle member and extending axially beyond the tip of the inner handle member, defining a see-through membrane, the needle being attached to the first outer handle member An elongated sheath attached and extending through the handle lumen and into the see-through lumen;
The medical device according to claim 11, comprising a cap slidably disposed at the proximal end of the first outer handle member and connected to the cell collection device.   14. The medical device of claim 13, further comprising an endoscope defining a working lumen, wherein the elongate sheath extends axially into the working lumen of the endoscope.   12. The medical device of claim 11, wherein the handle comprises one of a finger loop type handle, a pin-vise type handle, and a half finger loop type handle.   The endoscope of claim 1, further comprising an endoscope that includes a transducer that emits ultrasound and uses the ultrasound to measure the position of the cell harvesting device within the body of the mammal. Medical instrument.   The cell collection device includes a hollow wire having a proximal end, a distal end, and a plurality of bristles, and the transducer emits an ultrasonic wave that can be reflected by the hollow wire. The medical device according to claim 16.   The cell collection device includes an elongated member having a proximal end, a distal end, and a plurality of bristles, and the transducer emits ultrasonic waves that can be reflected by the plurality of bristles. The medical device according to claim 16.   19. The medical device of claim 18, wherein the plurality of bristles are made of one or more of nylon, brass, stainless steel, metal, carbon, and polymer.   The medical device of claim 1, wherein the stylet is a solid rod.   The medical device according to claim 1, wherein the stylet is made of one or more of steel, metal, and nitinol.   The cell collection device fits within the inner lumen of the needle when it is contracted, and when it is outside the inner lumen of the needle, the side is swollen to collect a cell sample. The medical device according to claim 1, comprising a balloon.   23. The medical device of claim 22, wherein the outer surface of the balloon is rough.   23. The medical device of claim 22, wherein the balloon is made of one or more of polymer, silicone, and polyethylene terephthalate.   The marker according to claim 1, further comprising a marker in the vicinity of the proximal end of the cell collection device for indicating when the tip of the cell collection device extends beyond the tip of the needle. Medical instruments.   The medical device of claim 1, wherein the tip of the stylet is adapted to cut the cell specimen.   27. The medical device of claim 26, wherein the tip of the stylet is sharp.   27. The medical device of claim 26, wherein the tip of the stylet is adapted to extend beyond the tip of the needle.   The outer surface of the stylet has a first diameter, the inner surface of the needle has a second diameter slightly larger than the first diameter, and the outer surface of the stylet The medical device of claim 1, wherein the medical device is configured to contact the inner surface of the needle and occlude the inner lumen of the needle while the needle is cut.   The medical instrument according to claim 1, wherein the cell collection device comprises a wire mesh device. In a medical device for collecting cell specimens from the mammalian body,
An endoscope containing a transducer and defining a working lumen;
A member having a proximal end, a distal end, and an inner lumen and extending into the working lumen of the endoscope;
A cell collection device having a proximal end and a cell collection tip, wherein the cell collection device is inserted into the inner lumen of the member; A cell collection device adapted to extend beyond the tip of the member for collection;
The transducer emits ultrasound and uses the ultrasound to measure the position of the cell collection device within the mammal.   32. The medical device of claim 31, wherein the cell collection device comprises an elongate member having a proximal end, a distal end, and a plurality of bristles.   33. The medical device of claim 32, wherein the elongate member comprises a recessed wire and the transducer is adapted to emit ultrasonic waves that can be reflected to the recessed wire.   33. The medical device of claim 32, wherein the transducer is adapted to emit ultrasonic waves that can be reflected by the plurality of bristles.   35. The medical device of claim 34, wherein the plurality of bristles are made of one or more of nylon, brass, stainless steel, metal, carbon, and polymer.   32. The medical device of claim 31, wherein the member is a needle.   32. The medical device of claim 31, wherein the tip of the cell collection device terminates in one of a cap, ball tip, conical tip, umbrella tip, and loop.   38. The medical device of claim 37, wherein one of the cap, ball tip, conical tip, umbrella tip, and loop is made of one or more of steel, metal, and solder. .   33. The medical device of claim 32, wherein the elongate member comprises a wire, and the wire is twisted to wrap around the plurality of bristles.   40. The medical device of claim 39, wherein the wire is made of one or more of steel, metal, and nitinol.   34. The medical device of claim 32, wherein the elongate member tip is adapted to be retracted into the inner lumen of the needle after collection of the cell sample.   32. The medical device of claim 31, wherein the member is made of one or more of steel and metal.   32. The medical device of claim 31, wherein the member is adapted to perform aspiration.   32. The medical device of claim 31, further comprising a handle adapted to move the cell collection device and the member in an axial direction. The handle is:
An inner handle member having a proximal end and a distal end;
A first outer handle member slidably disposed on the inner handle member;
An elongate sheath attached to the inner handle member and extending axially beyond the tip of the inner handle member, defining a see-through membrane, the member being attached to the first outer handle member 45. The medical device of claim 44, attached and disposed within the see-through membrane. The handle is:
An inner handle member having a proximal end and a distal end and defining a handle lumen;
A first outer handle member slidably disposed on the proximal end of the inner handle member;
A second outer handle member slidably disposed on the tip of the inner handle member;
An elongate sheath attached to the inner handle member and extending axially beyond the tip of the inner handle member, defining a see-through membrane, the member being attached to the first outer handle member An elongated sheath attached and extending through the handle lumen and into the see-through lumen;
45. The medical device of claim 44, comprising a cap slidably disposed at the proximal end of the first outer handle member and connected to the cell collection device.   47. The medical device of claim 46, wherein the elongate sheath extends axially into the working lumen of the endoscope.   45. The medical device of claim 44, wherein the handle comprises one of a finger loop type handle, a pin-vise type handle, and a half finger loop type handle.   The cell collection device is adapted to fit within the inner lumen of the member when contracted, and to swell to collect the cell sample when outside the inner lumen of the member. 32. The medical device of claim 31, comprising a balloon.   50. The medical device of claim 49, wherein the outer surface of the balloon is rough.   50. The medical device of claim 49, wherein the balloon is made of one or more of polymer, silicone, and polyethylene terephthalate.   The marker of claim 31, further comprising a marker adapted to indicate when the tip of the cell collection device extends beyond the tip of the member near the proximal end of the cell collection device. Medical instruments. In a method for collecting a cell sample from a mammalian body:
A needle having a proximal end, a distal end, and an inner lumen extending from the proximal end to the distal end; a stylet having a proximal end and a distal end; and a cell collection having a proximal end and a distal end for cell collection Providing a device comprising: a device;
Inserting the stylet into the inner lumen of the needle, wherein at least a portion of the stylet plugs and inserts the inner lumen of the needle;
Excising an area in the mammal's body;
Withdrawing the stylet from the inner lumen of the needle;
Inserting the cell harvesting device into the inner lumen of the needle such that the tip of the cell harvesting device extends beyond the tip of the needle;
Using the cell collection device to collect the cell sample from the mammalian body;
Retracting the tip of the cell harvesting device into the inner lumen of the needle.   54. The method of claim 53, wherein the cell harvesting device comprises an elongate member having a proximal end, a distal end, and a plurality of bristles.   54. The method of claim 53, wherein the tip of the cell harvesting device terminates in one of a cap, ball tip, conical tip, umbrella tip, and loop.   56. The method of claim 55, wherein one of the cap, ball tip, conical tip, umbrella tip, and loop is made of one or more of steel, metal, and solder.   55. The method of claim 54, wherein the elongate member comprises a wire, and the wire is twisted to wrap around the plurality of bristles.   58. The method of claim 57, wherein the wire is made of one or more of steel, metal, and nitinol.   54. The method of claim 53, wherein the needle is made of one or more of steel and metal.   55. The method of claim 54, wherein the plurality of bristles are made of one or more of nylon, brass, stainless steel, metal, carbon, and polymer.   54. The medical device of claim 53, further comprising performing suction through the needle.   The prepared device further comprises a handle adapted to move the stylet axially, move the cell collection device axially, and move the needle axially at various times. 54. The method of claim 53, wherein: The handle is:
An inner handle member having a proximal end and a distal end;
A first outer handle member slidably disposed on the inner handle member;
An elongate sheath attached to the inner handle member and extending axially beyond the tip of the inner handle member, defining a see-through membrane, the needle being attached to the first outer handle member 63. A method according to claim 62, comprising an elongated sheath attached and disposed within the see-through membrane. The handle is:
An inner handle member having a proximal end and a distal end and defining a handle lumen;
A first outer handle member slidably disposed on the proximal end of the inner handle member;
A second outer handle member slidably disposed on the tip of the inner handle member;
An elongate sheath attached to the inner handle member and extending axially beyond the tip of the inner handle member, defining a see-through membrane, the needle being attached to the first outer handle member An elongate sheath attached and wherein the needle extends through the handle lumen and into the see-through lumen;
63. A method according to claim 62, comprising a cap slidably disposed at the proximal end of the first outer handle member and connected to the stylet.   The cap is attached to the proximal end of the stylet, inserting the stylet into the inner lumen of the needle, cutting away an area within the body, and removing the stylet from the needle. 65. The method of claim 64, wherein the steps of withdrawing from the inner lumen are all accomplished by sliding the cap axially. The handle
An inner handle member having a proximal end and a distal end and defining a handle lumen;
A first outer handle member slidably disposed on the proximal end of the inner handle member;
A second outer handle member slidably disposed on the tip of the inner handle member;
An elongate sheath attached to the inner handle member and extending axially beyond the tip of the inner handle member, defining a see-through membrane, the needle being attached to the first outer handle member An elongated sheath attached and extending through the handle lumen and into the see-through lumen;
64. A method according to claim 62, comprising a cap slidably disposed at the proximal end of the first outer handle member and connected to the cell harvesting device.   The cap is attached to the proximal end of the cell collection device; inserting the cell collection device into the inner lumen of the needle; collecting the cell sample from the body; and the cell collection device 68. The method of claim 66, wherein retracting the needle into the inner lumen of the needle is all accomplished by sliding the cap axially.   The prepared apparatus further comprises an endoscope defining a working lumen, and the elongated sheath extends axially into the working lumen of the endoscope. 66. The method according to 66.   64. The method of claim 62, wherein the handle comprises one of a finger loop type handle, a pin-vise type handle, and a half finger loop type handle.   The prepared apparatus further includes an endoscope with a built-in transducer adapted to emit ultrasonic waves, and the method includes collecting the cells in the mammalian body using ultrasonic waves emitted by the transducers. 54. The method of claim 53, further comprising the additional step of measuring the position of the device.   The cell collection device has a hollow wire having a proximal end, a distal end, and a plurality of bristles, and the transducer emits an ultrasonic wave that can be reflected by the hollow wire. 71. The method of claim 70.   The cell collection device has an elongated member having a proximal end, a distal end, and a plurality of bristles, and the transducer is adapted to emit ultrasonic waves that can be reflected by the plurality of bristles. Item 70. The method according to Item 70.   75. The method of claim 72, wherein the plurality of bristles are made of one or more of nylon, brass, stainless steel, metal, carbon, and polymer.   54. The method of claim 53, wherein the stylet is a solid rod.   54. The method of claim 53, wherein the stylet is made of one or more of steel, metal, and nitinol.   The cell collection device is adapted to fit within the inner lumen of the needle when contracted, and to swell to collect the cell sample when outside the inner lumen of the needle. 54. The method of claim 53, comprising a balloon.   77. The method of claim 76, wherein the outer surface of the balloon is rough.   77. The method of claim 76, wherein the balloon is made of one or more of polymer, silicone, and polyethylene terephthalate.   54. The marker of claim 53, further comprising a marker near the proximal end of the cell collection device for indicating when the tip of the cell collection device extends beyond the tip of the needle. the method of.   54. The method of claim 53, wherein the tip of the stylet is used to cut a region within the mammalian body.   81. The method of claim 80, wherein the tip of the stylet is sharp.   81. The method of claim 80, wherein when the stylet is inserted into the inner lumen of the needle, the tip of the stylet extends beyond the tip of the needle.   The outer surface of the stylet has a first diameter, the inner surface of the needle has a second diameter slightly larger than the first diameter, and the outer surface of the stylet 54. The method of claim 53, wherein the inner lumen of the needle is occluded against the inner surface of the needle while the region is cut away.   54. The method of claim 53, wherein the cell collection device comprises a wire mesh device. In a method for collecting a cell sample from a mammalian body,
An endoscope defining a working lumen and incorporating a transducer; a member having a proximal end and a distal end and extending into the working lumen of the endoscope; a proximal end and a cell collection distal end Providing a device comprising: a cell collection device extending into the inner lumen of the member; and
Inserting the working lumen of the endoscope into the body of the mammal;
Extending the tip of the cell collection device beyond the tip of the member;
Emitting ultrasound from the transducer of the endoscope;
Reflecting the ultrasound to the cell collection device;
Receiving the reflected ultrasound using the transducer of the endoscope;
Measuring the position of the cell collection device within the mammal.   86. The method of claim 85, wherein the cell harvesting device comprises an elongated member having a proximal end, a distal end, and a plurality of bristles.   86. The method of claim 85, wherein the tip of the cell harvesting device terminates in one of a cap, ball tip, conical tip, umbrella tip, and loop.   88. The method of claim 87, wherein one of the cap, ball tip, conical tip, umbrella tip, and loop is made of one of steel, metal, and heel.   87. The method of claim 86, wherein the elongate member comprises a wire, and the wire is twisted to wrap around the plurality of bristles.   90. The method of claim 89, wherein the wire is made of one or more of steel, metal, and nitinol.   86. The method of claim 85, wherein the member is made of one or more of steel and metal.   87. The method of claim 86, wherein the plurality of bristles are made of one or more of nylon, brass, stainless steel, metal, carbon, and polymer.   86. The method of claim 85, further comprising performing suction through the member.   86. The method of claim 85, wherein the member is a needle.   86. The method of claim 85, wherein the prepared device further comprises a handle adapted to move the member axially and to move the cell harvesting device axially at various times. The handle is:
An inner handle member having a proximal end and a distal end;
A first outer handle member slidably disposed on the inner handle member;
An elongate sheath attached to the inner handle member and extending axially beyond the tip of the inner handle member, defining a see-through membrane, the member being attached to the first outer handle member 96. A method according to claim 95, comprising an elongated sheath attached and disposed within the see-through membrane. The handle is:
An inner handle member having a proximal end and a distal end and defining a handle lumen;
A first outer handle member slidably disposed on the proximal end of the inner handle member;
A second outer handle member slidably disposed on the tip of the inner handle member;
An elongate sheath attached to the inner handle member and extending axially beyond the distal end of the inner handle member, defining a see-through membrane, the member comprising the first outer handle member An elongate sheath attached to and extending through the handle lumen and into the see-through lumen;
96. A method according to claim 95, comprising a cap slidably disposed at the proximal end of the first outer handle member and connected to the cell harvesting device.   The cap is attached to the proximal end of the cell collection device, and the step of extending the tip of the cell collection device beyond the tip of the member is by sliding the cap in the axial direction. 98. The method of claim 97, realized.   98. The method of claim 97, wherein the elongate sheath extends axially into the working lumen of the endoscope.   96. The method of claim 95, wherein the handle comprises one of a finger loop type handle, a pin-vise type handle, and a half finger loop type handle.   The cell collection device includes a hollow wire having a proximal end, a distal end, and a plurality of bristles, and the transducer emits an ultrasonic wave that can be reflected by the hollow wire. 86. The method of claim 85.   The cell collection device includes an elongated member having a proximal end, a distal end, and a plurality of bristles, and the transducer emits ultrasonic waves that can be reflected by the plurality of bristles. 90. The method of claim 85.   105. The method of claim 102, wherein the plurality of bristles are made of one or more of nylon, brass, stainless steel, metal, carbon, and polymer.   The cell collection device is adapted to fit within the inner lumen of the member when contracted, and to swell to collect the cell sample when outside the inner lumen of the member. 86. The method of claim 85, comprising a balloon.   105. The method of claim 104, wherein the outer surface of the balloon is rough.   105. The method of claim 104, wherein the balloon is made of one or more of polymer, silicone, and polyethylene terephthalate.   86. A marker near the proximal end of the cell collection device, further comprising a marker adapted to indicate when the tip of the cell collection device extends beyond the tip of the member. the method of.

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